with TRESIBA may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take TZDs with TRESIBA. Your healthcare provider should monitor you closely while you are taking TZDs with TRESIBA. Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet and sudden weight gain. Treatment with TZDs and TRESIBA may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
Your insulin dose may need to change because of:
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change in level of physical activity or exercise
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weight gain or loss
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increased stress
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illness
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change in diet
Common side effects of TRESIBA may include:
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serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain.
Get emergency medical help if you have:
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trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.
These are not all the possible side effects of TRESIBA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of TRESIBA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about TRESIBA that is written for health professionals. Do not use TRESIBA for a condition for which it was not prescribed. Do not give TRESIBA to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in TRESIBA?
Active Ingredient: insulin degludec
Inactive Ingredients: zinc, metacresol, glycerol, phenol, and water for injection. Hydrochloric acid or sodium hydroxide may be added.
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark
For more information, go to www.novonordisk-us.com or call 1-800-727-6500.
This Patient Information has been approved by the U.S. Food and Drug Administration
Revised: 09/2015
Instructions for Use
TRESIBA® (tre-SI-bah) FlexTouch® Pen 100 units/mL
(insulin degludec injection)
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Do not share your TRESIBA FlexTouch Pen with other people, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them.
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TRESIBA FlexTouch Pen 100 units/mL (“Pen”) is a prefilled disposable pen containing 300 units of TRESIBA (insulin degludec injection) 100 units/mL insulin. You can inject from 1 to 80 units in a single injection. The units can be increased by 1 unit at a time.
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This Pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.
Supplies you will need to give your TRESIBA injection:
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TRESIBA FlexTouch Pen
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a new NovoFine or NovoTwist needle
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alcohol swab
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a sharps container for throwing away used Pens and needles. See “After your injection” at the end of th
